| Abstract | BACKGROUND: Superficial pyodermas may require systemic antibiotics. In a previous open-label trial, oxacillin and pristinamycin achieved similar cure rates, but its design was not truly that of a non-inferiority study. OBJECTIVES: To assess the efficacy and safety of oral cloxacillin versus pristinamycin (both 2 g/day) to treat superficial pyodermas. METHODS: Multicentre, parallel-group, open-label, randomized non-inferiority trial. RESULTS: French general practitioners in private practice included 334 out-patients (mean age: 42 years). At the follow-up (day 14), the cure rates (primary efficacy end point) for the intent-to-treat populations were 80.7% (138/171) for cloxacillin and 82.8% (135/163) for pristinamycin. The observed difference between cure rates was -2.1%, with the lower limit of the two-sided 95% confidence interval higher than the non-inferiority threshold of -15%. The per-protocol analysis yielded similar results. Therapy was discontinued for 10 patients (cloxacillin: 1, pristinamycin: 9; p = 0.01). CONCLUSION: Cloxacillin could be an alternative to pristinamycin in out-patients with superficial pyodermas. |
| Authors | O Chosidow, P Bernard, P Berbis, P Humbert, B Crickx, V Jarlier, ORPIC Study Investigator Group
(Affiliation: Department of Internal Medicine, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris and Université Paris-VI, France. olivier.chosidow at psl.ap-hop-paris.fr)
|
| Journal | Dermatology (Basel, Switzerland)
(Dermatology)
Vol. 210
Issue 4
Pg. 370-4
( 2005)
ISSN: 1018-8665 Switzerland |
| PMID | 15942235
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
| Copyright | 2005 S. Karger AG, Basel |
| Chemical References |
- Pristinamycin
- Cloxacillin
|
| Topics |
- Administration, Oral
- Cloxacillin
(administration & dosage)
- Confidence Intervals
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Follow-Up Studies
- France
- Humans
- Male
- Pristinamycin
(administration & dosage)
- Pyoderma
(diagnosis, drug therapy)
- Reference Values
- Severity of Illness Index
- Single-Blind Method
- Treatment Outcome
|
